Orange Book product · Brand (NDA)
SER-AP-ES
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
Strength
25MG;15MG;0.1MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 012193
Product number
005
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1984RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 088570 · SUN PHARM INDUSTRIES
- 1983RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 088376 · SOLVAY
- 1982RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 087709 · LEDERLE
- —CAM-AP-ESGeneric (ANDA)
ANDA 084897 · CHARTWELL RX
- —HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINEGeneric (ANDA)
ANDA 084291 · IVAX SUB TEVA PHARMS
- —HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINEGeneric (ANDA)
ANDA 087085 · MYLAN
- —HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINEGeneric (ANDA)
ANDA 085771 · WATSON LABS
- —HYDRAP-ESGeneric (ANDA)
ANDA 084876 · SANDOZ
- —HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINEGeneric (ANDA)
ANDA 083770 · WATSON LABS
- —HYDROSERPINE PLUS (R-H-H)Generic (ANDA)
ANDA 083877 · IVAX SUB TEVA PHARMS
- —RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 085549 · WATSON LABS
- —RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 087556 · WATSON LABS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
